Analysis of Sleep Study Data to Assess Depressive Burden

NCT04232267 | Completed

• 1 other identifier: CIP-0018
• Study Type: observational
• Target: 329
• Locations: 1 country
• Sites: 5

Brief Summary

This study evaluates the effectiveness of the MEB-001 device in assessing physiological parameters that provide a clinically significant depressive burden screener. This study uses objective physiological markers from MEB-001 to estimate the clinically significant depressive burden as subjectively reported by the subject with the Beck Depression Inventory - II (BDI-II).

Conditions

Sleep Disorder; Depressive; Behavioral Disorder; Mood Disorders

Outcome Measures

Primary Outcomes (2)

• Report assists in the detection of clinically significant depressive burden.

  Utilize PSG data and BDI-II to determine clinical depressive burden.

  The study consists of 1 study visit (baseline).

• Evaluate algorithm accuracy, sensitivity and specificity.

  Sensitivity: True Positive/BDI-II + (the percentage of BDI-II positives identified by MEB-001) Specificity: True Negative/BDI-II - (the percentage of BDI-II negatives identified by MEB-001)

  The study consists of 1 study visit (baseline).

Secondary Outcomes (2)

• Evaluate positive predictive value and negative predictive value in detecting clinically significant depressive burden.

  The study consists of 1 study visit (baseline).

• System reliability and internal consistency.

  The study consists of 1 study visit (baseline).

Study Arms (1)

Patients prescribed Polysomnology (PSG - sleep study)

Patients that are at least 18 years old but not older than 75 years old, who have been referred to a sleep clinic for sleep disturbance.

Device: MEB-001

Interventions

MEB-001 DEVICE

Software medical device used to aid in the screening of patients with potential depressive burden symptoms.

Patients prescribed Polysomnology (PSG - sleep study)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who are at least 18 years old but not older than 75 years old, who have been referred to a sleep clinic for sleep disturbances and sign an informed consent form (ICF) will be eligible to participate in this study.

You may qualify if:

• Subject is age ≥18 years and ≤75 years.
• Subject is willing and able to provide consent.
• Subject has the ability to read and understand the instructions for the study.
• Subject is willing to adhere to study procedures.
• Subject is willing to undergo full night PSG study, as prescribed.

You may not qualify if:

• Subject has a pacemaker.
• Subject is suspected or known to have active alcohol or drug abuse (including but not limited to abuse of marijuana).

Sponsors & Collaborators

• Medibio Limited: lead

Study Sites (5)

Restore Sleep Clinic

Blaine, Minnesota, 55434, United States

Location

Lakeland Sleep and CPAP

Plymouth, Minnesota, 55441, United States

Location

Ohio Sleep Solutions

Columbus, Ohio, 43214, United States

Location

Ohio Sleep Solutions

Grove City, Ohio, 43123, United States

Location

Ohio Sleep Solutions

Hilliard, Ohio, 43026, United States

Location

MeSH Terms

Conditions

Sleep Wake Disorders; Mental Disorders; Mood Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Melissa Bruner

  Medibio Limited

  STUDY DIRECTOR

• Archie Defillo, MD

  Medibio Limited

  STUDY CHAIR

• Archie Defillo, MD

  Medibio Limited

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2020
• First Posted: January 18, 2020
• Study Start: January 13, 2020
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: December 21, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)